Bone Density, Low, Chronic Kidney Diseases, End Stage Renal Disease, Fracture
Conditions
Keywords
Denosumab, Chronic Kidney Diseases, Treatment, Fracture
Brief summary
Objective: To verify the efficacy and safety of denosumab in the prevention and treatment of CKD-MBD in CKD patients with high risk of fracture. Methods: A cohort of CKD patients with high risk of fracture was established and followed up for long periods (≥24 months). Patients with CKD3b-5D stage and fracture risk assessment tool (FRAX) scores at high risk or very high risk of fracture were enrolled. A multicenter, prospective, open-label, randomised controlled, interventional study was conducted. The patients were divided into two groups. The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months, and the patients in the non-denosumab group received conventional treatment. Bone metabolic markers (serum calcium, phosphorus, vitamin D, parathyroid hormone, alkaline phosphatase, tartrate-resistant acid phosphatase 5b, osteocalcin, total N-terminal propeptide of type I collagen, etc.), bone mineral density (dual-energy X-ray, quantitative CT), and vascular calcification score were regularly monitored. All adverse events (all-cause death, cardiovascular death, cardiac events, fracture, hospitalization, emergency department visits, etc.) were recorded during the follow-up period. Bone mineral density and clinical parameters were compared between the two groups.
Interventions
DRUGDenosumab
The patients in the denosumab group received subcutaneous injection of denosumab 60mg once every 6 months for 24 months.
DRUGNon-denosumab
Taken other medications, such as diphosphonates, active vitamin D and/or active vitamin D analogue, calcimimetics, calcitonin, estrogen receptor agonists, etc.
Sponsors
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* ≥18 years old; * Stage 3b-5D chronic kidney disease; * The 10-year probability of hip fracture assessed by fracture risk assessment tool (FRAX) was \>5%; * Voluntarily signed informed consent.
Exclusion criteria
* Age \< 18 or ≥100 years; * Premenopausal women; * Denosumab was absolutely contraindicated; * Had received denosumab or bisphosphonates therapy; * Tertiary hyperparathyroidism; * Patients with malignant tumor; * Patients at risk for osteonecrosis of the jaw; * Estimated follow-up time ≤12 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bone mineral density (BMD) decline at the lumbar spine | 24 months | Rate of BMD decline =\[(BMD24-BMD Baseline)÷BMD baseline\]\*100% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of fresh fractures, cardiovascular cerebrovascular adverse events and all-cause mortality | 24 months | Fresh fractures were new non-traumatic fractures during follow-up. Cardiovascular cerebrovascular adverse events were Acute myocardial infarction, heart failure, shock, cardiac arrest, stroke, and lower limb arterial occlusion occurred during follow-up. All-cause mortality was death from any cause during follow-up. |
Countries
China
Contacts
Primary ContactDongliang Zhang, Director
Outcome results
None listed